Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
Conditions
Keywords
preterm infants, nasal continuous positive airway pressure, heliox, bronchopulmonary dysplasia.
Brief summary
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).
Interventions
OTHERNCPAP + standard air
NCAP (SiPAP, Vyasis) was used to administer standard air
OTHERNCPAP + Heliox
Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* inborn infants between 28 and 32 weeks of GA * Silverman score \> 5, * radiological finding of RDS * a requirement of inspiratory flow of oxygen (FiO2) \> 0,25 (SaO2 ) between 88-95% within the first hour of life.
Exclusion criteria
* major congenital malformations * intraventricular hemorrhage (IVH) more than grade 2 * need of intubation in the delivery room or requirement of FiO2 \>0,4 during the first hour of life.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in reducing need of MV | 7 days | efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surfactant need | participants will be followed for the duration of hospital stay, an expected average of 10 weeks | number of doses of exogenous surfactant |
| major complications of prematurity | participants will be followed for the duration of hospital stay, an expected average of 10 weeks | incidence of major complications of prematurity |
| ventilatory assistance | participants will be followed for the duration of hospital stay, an expected average of 10 weeks | number of days of ventilatory assistance |
| length of stay | participants will be followed for the duration of hospital stay, an expected average of 10 weeks | number of days of hospital stay |
Countries
Italy
Outcome results
None listed